On October 29, 2018 Principia Biopharma Inc. (Nasdaq: PRNB), a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported the appointment of industry veteran Dolca Thomas, M.D. as its Chief Medical Officer (Press release, Principia Biopharma, OCT 29, 2018, View Source [SID1234530295]). Dr. Thomas joins Principia from Roche, where she was Vice President and Global Head of Translational Medicine for Immunology, Inflammation, and Infectious Disease. She brings approximately 15 years of industry and medical experience to Principia. Steve Gourlay, MBBS, FRACP, Ph.D. will remain with the company as a senior medical advisor through mid-year 2019.

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"We are very excited with the addition of Dolca to the Principia team, particularly as we pursue an expanding scope of clinical development activities including initiating our pivotal Phase 3 trial for PRN1008 in patients with pemphigus. Dolca is a seasoned pharma executive with broad and successful experience in executing late stage programs, specifically in immunology," said Martin Babler, Chief Executive Officer of Principia. "I also want to thank Steve for his leadership, dedication and contributions to Principia over the past five years. Steve led the clinical development of three different molecules, including taking PRN1008 from its first-in-human trial through design and preparation for Phase 3. We are pleased that he will continue to support the company as a senior medical advisor through the first half of next year."

"I am impressed with Principia’s approach to BTK inhibition in autoimmune disease and believe that application of the company’s proprietary Tailored Covalency platform may be applicable across a wide range of autoimmune and inflammatory conditions," said Dr. Thomas. "I have been involved in more than a dozen immunology product candidates, and I look forward to contributing to the potential success of Principia’s pipeline assets and moving the company towards late-stage clinical development."

Dr. Thomas brings 15 years of industry and medical experience with strategic and operational responsibility for clinical development, pharmacovigilance, and safety and medical affairs of approximately two dozen pharmaceutical products. Most recently, Dr. Thomas was Vice President and Global Head of Translational Medicine for Immunology, Inflammation, and Infectious Disease at Roche, where she was responsible for advancing multiple product candidates through clinical development. Prior to Roche, Dr. Thomas held roles of increasing responsibility at Pfizer, including Vice President of Clinical Development and Clinical Immunophenotyping, and Vice President and Chief Development Officer of the Biosimilars Research and Development Unit where she was responsible for all stages of development of multiple assets. Dr. Thomas began her industry career at Bristol-Myers Squibb as Director of Global Clinical Development in Immunology, where she was involved in the development and approval of belatacept.

Dr. Thomas has a B.A. in sociology from Cornell University, and received her M.D. degree from Cornell University. Dr. Thomas completed her residency in internal medicine, in addition to her post-doctoral training in nephrology and transplantation, at New York- Presbyterian Hospital, Weill Cornell Medical Center.

Dr. Thomas represented both Bristol-Myers Squibb and Pfizer on the Board of Directors of the Progressive Multifocal Leukoencephalopathy (PML) Consortium, a cross-industry consortium aimed at identifying more effective methods of predicting, preventing, and developing future treatments for PML. Dr. Thomas has many past collaborations with the Juvenile Diabetes Research Foundation (JDRF) where she has been the recipient of multiple JDRF research grants and awards. In addition, she served on Board of Directors for the NYC JDRF chapter.

On October 29, 2018 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended September 30, 2018 (Press release, Vical, OCT 29, 2018, View Source [SID1234530293]). Net loss for the third quarter of 2018 was $1.5 million, or $0.07 per share, compared with a net loss of $3.1 million, or $0.27 per share, for the third quarter of 2017. Revenues for the third quarter of 2018 were $0.1 million, compared with revenues of $3.2 million for the third quarter of 2017, reflecting a reduction in revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements. Net loss for the third quarter of 2018 included a gain of $2.3 million related to the sale of the Company’s manufacturing assets and $0.7 million received from Astellas to cover close down costs related to the ASP0113 program.

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Vical had cash, cash equivalents, marketable securities and long-term investments of $52.7 million at September 30, 2018. The Company’s cash burn for the third quarter of 2018 was $1.6 million. The Company is updating its 2018 full year cash burn guidance to a range of between $15 million and $18 million, a reduction in cash burn from its previous forecast of between $20 million and $24 million. The Company anticipates ending 2018 with a minimum of $45 million in cash, cash equivalents, marketable securities and long-term investments.

Vical recently announced plans to explore a range of strategic options to enhance shareholder value. The company retained MTS Health Partners, L.P. to assist in the strategic review process. There is no set timetable for the review process and there can be no assurance that the process will result in a transaction.

Program updates include:

VL-2397 Antifungal Candidate

The multinational Phase 2 registration trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant is ongoing (ClinicalTrials.gov Identifier: NCT03327727). Vical expects to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. Centers are now open for enrollment in the US, Canada, Belgium, Germany, and will open shortly in South Korea. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals.
VR-CHB01 Hepatitis B Virus (HBV) Therapeutic Candidate

The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. The Company expects to complete the initial stage of preclinical development in the fourth quarter of 2018

On October 29, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that Dr. Ramesh Kumar, CEO, will be meeting with potential Investors and Business Development partners at the 2018 Bio-Europe International Partnering Conference in Copenhagen (Press release, Onconova, OCT 29, 2018, View Source [SID1234530289]).

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Dates: Monday – Wednesday, November 5-7, 2018
Venue: Bella Center – Copenhagen, Denmark

On October 29, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that it will release third quarter 2018 financial results after the market closes on Monday, November 5, 2018 (Press release, Xencor, OCT 29, 2018, View Source [SID1234530286]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers, and referencing conference ID number 5577136. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 90 days

On October 29, 2018 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported its update on its successful transition to a new diagnostic testing platform and initiation of a series of studies designed to make its DetermaVu lung cancer assay available for the medical market in the second half of 2019 (Press release, BioTime, OCT 29, 2018, View Source;p=RssLanding&cat=news&id=2373980 [SID1234530283]).

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OncoCyte has completed its transition to an industry standard Next Generation Sequencing (NGS) diagnostic testing platform, including installation, training and operational qualification. The Company has also completed incoming quality control and testing of its custom panel reagents. As anticipated, the new platform appears to be generating consistent and reliable data.

Based on these positive results, OncoCyte has initiated the 700-blood sample Algorithm Development Study to establish a proprietary mathematical algorithm that will be used to interpret test results for DetermaVu.

"We are pleased to complete the transition to our new diagnostic testing platform, an important step forward as we continue to advance DetermaVu toward commercialization," said William Annett, President and Chief Executive Officer. "With the platform in place and generating reliable test results, we look forward to completing our critical R&D Validation Study around year-end. Assuming we are successful with that study, we will be on-track to complete all of the necessary pre-launch studies in the first half of 2019. We believe DetermaVu can alter the treatment paradigm in lung cancer diagnostics by reducing the number of expensive, risky and unnecessary biopsies, thereby saving lives while lowering healthcare costs. If high accuracy is confirmed in the planned studies, DetermaVu could address an estimated $4.7 billion annual market in the U.S. for confirmatory lung cancer liquid biopsy tests, depending on pricing, market penetration, and the attainment of Medicare and private payer reimbursement."

Management will provide an update on DetermaVu development during its next regularly-scheduled quarterly results conference call in mid-November.

DetermaVu Development Path

To provide an initial assessment of the accuracy of DetermaVu, OncoCyte will analyze and cross-validate a proprietary DetermaVu algorithm in multiple clinical subsets using 700 blood samples gathered from patients. OncoCyte has discovered or in-licensed almost 800 biomarkers that may, in combination, differentiate between malignant and benign lung nodules. The optimal combination and weighting of biomarkers in the algorithm will be determined through bioinformatics combined with the latest algorithm development strategies that may include artificial intelligence (AI) related methods.

This study follows an earlier 2018 study of DetermaVu on approximately 155 clinical samples that resulted in accuracy (as measured by Area Under the Curve data) at least equivalent to the DetermaVu lung cancer test results previously reported in May 2017 at the American Thoracic Society 2017 International Conference (ATS). Those results demonstrated sensitivity of 95%, specificity of 73%, and Area Under the Curve (AUC) of 0.92, meaning that 92% of samples were correctly identified. Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of benign nodules correctly identified. Because the error bar or potential range of results from the small sample set in the 2018 study is wide, these results must now be confirmed in a larger sample set.

Upon completing the Algorithm Development Study, OncoCyte plans to initiate an R&D Validation Study to confirm the accuracy of DetermaVu in a research setting. This R&D Validation Study will analyze approximately 250 blinded, prospectively collected patient blood samples to confirm the sensitivity and specificity of DetermaVu to within approximately plus or minus 8 percentage points. Expected about year end, results of the R&D Validation Study should provide a strong indication of whether DetermaVu has sufficient accuracy for medical use.

If OncoCyte achieves positive R&D Validation study results, the next step will be to conduct an Analytical Validation Study to establish the performance characteristics of DetermaVu, which will then be validated in the Company’s CLIA laboratory. Finally, as the last step in the DetermaVu development process, a blinded prospective Clinical Validation Study of DetermaVu would be conducted in the first half of 2019.

All clinical samples required for each of these DetermaVu studies are currently in-house, and available for testing. In total OncoCyte has blood samples from over 2,000 patients.

About DetermaVu

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures to determine if the nodules are malignant. OncoCyte estimates that a $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on market penetration and reimbursable pricing.

DetermaVu is a trademark of OncoCyte Corporation.